CCB Safety Study in Treatment of Hypertension of ADPKD

Kidney, Polycystic, Autosomal Dominant Clinical Trial

Official title:

Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00541853
• Other study ID #: ADPKDCCB
• Status: Unknown status
• Phase: Phase 4
• First received: October 9, 2007
• Last updated: October 17, 2007
• Start date: December 2007
• Est. completion date: November 2012

Study information

• Verified date: October 2007
• Source: Kyorin University
• Contact: Eiji Higashihara, M.D.
• Phone: +81-422-47-5511
• Email: ehigashi[@]kyorin-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• ADPKD patients.

• Blood pressure measured at out-patient setting is above 130/85 mmHg.

• Age between 20 and 60 years old.

• Plasma creatinine less than 2.0mg in man and 1.5mg in woman.

• Patients give informed consent.

Exclusion Criteria:

• Patients with severe cardiovascular and hepatic disorders.

• Patients with complications of central nervous vascular disorders.

• Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.

• Patients currently engaging in other experimental protocol.

• Patients with intracranial aneurysma.

• Patients who must use diuretics.

• Allergic patients to Candesartan or Cilnidipine.

• Patients whose hypertension is not controlled by medication of this protocol.

Related Conditions & MeSH terms

• Kidney, Polycystic, Autosomal Dominant
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Candesartan
Candesartan upto 8mg
• Candesartan and Cilnidipine
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
• Candesartan plus non-CCB agents
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI

Locations

Country	Name	City	State
Japan	Department of Urology, National Hospital Organaization Chiba-East Hospital	Chiba, Chiba
Japan	Toranomon Hospital Kajigaya, Kidney center	Kanagawa
Japan	Kyorin University School of Medicine	Mitaka	Tokyo
Japan	Department of Urology, Teikyo University, School of Medicine	Tokyo
Japan	Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine	Tokyo
Japan	Toranomon Hospital, Kidney center	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Kyorin University	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney Volume measured by MRI.		Every year
Secondary	Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events		any time during study period